The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: UFT (uracil, tegafur) and tamoxifen; Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152178

91023033

Details and patient eligibility

About

This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.

Enrollment: 680 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 20 to 65
• Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL
• Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
• Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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680 participants in 2 patient groups

1

Experimental group

Description:

UFT (uracil, tegafur) and tamoxifen

Treatment:

Drug: UFT (uracil, tegafur) and tamoxifen

2

Active Comparator group

Description:

CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Treatment:

Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen